Angiodynamics Inc. (Navilyst Medical Inc.): Medical Device Recall in 2021 - (Recall #: Z-2617-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995

Product Classification:

Class II

Date Initiated: October 17, 2017

Date Posted: October 6, 2021

Recall Number: Z-2617-2021

Event ID: 88596

Reason for Recall:

Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).

Status: Terminated

Product Quantity: 4 boxes (5/each)= 20 eaches

Code Information:

Lot Number: 5210162 (UDI): H96560M7019951

Distribution Pattern:

Canada

Voluntary or Mandated:

Voluntary: Firm initiated